Savvy Long PTA Dilatation Catheter 436-5015XRecalls & reported problems
Clearstream Technologies Limited · Savvy Long PTA Dilatation Catheter 5.0mm x 150mm balloon, 150cm shaft · Class 2
All models of Savvy Long PTA Dilatation Catheter (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741133305), received between Mar 7, 2018 and Mar 7, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE, AFTER THE DEVICE WAS REMOVED FROM THE PACKAGING, THE BALLOON WAS IDENTIFIED ALLEGEDLY DETACHED FROM THE DELIVERY SYSTEM. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7321781 ↗
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- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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